Surgical Techniques

PEP Topic

Lymphedema

Description

A variety of surgical and microsurgical techniques have been examined for prevention or treatment of lymphedema in patients with cancer. Techniques include harvesting tissue from nonsurgical sites, such as lymph nodes and vascular structures, and transplanting to the area operated on for tumor removal. Techniques to attempt to preserve specific veins at the time of surgery and creation of lymphatic-venous anastomosis also have been used. Surgical interventions include use of different types of surgical closure.

Used a comparison group (control) derived from the same population of patients who suffered the same condition.

Included a cohort of patients with matching demographics, gender, comorbidities, and other forms of treatment, such as radiation therapy.

Used the same surgical technique for prevention of lymphedema and other complications.

Included a sufficient follow-up period to evaluate the development of chronic complications.

Lymphedema has been defined clearly based on limb girth measurements.

The authors did not list the exclusion criteria. However, in the results section, the authors mentioned that two studies were excluded from the meta-analysis because they did not focus on the effect of saphenous vein preservation.

Literature Evaluated:

Suitable studies were assessed using the Newcastle-Ottawa scale for evaluation of the quality of nonrandomized cohort studies. This scale uses a star system for evaluation of nonrandomized studies. The grading is based on three criteria: patient selection, comparability of study groups, and outcome assessment. The analysis included studies that scored 6 stars or higher and were considered suitable for inclusion in the meta-analysis. The total number of studies initially reviewed was 14. Of these, 12 were included in the report and 4 in the meta-analysis.

Meta-analysis was conducted with the studies that reported on saphenous vein preservation. The rest were individual reports and were not pooled. The primary outcome was the rates of leg lymphedema. Other outcomes, such as cellulitis, flap necrosis, lymphocele, the number of harvested nodes, and rate of cancer recurrence, were considered secondary endpoints. Studies deemed suitable according to the Newcastle-Ottawa scale were pooled, and the data was entered in ‘‘Metaview’’, which is used by the Cochrane methods for systematic reviews. All of the results were analyzed as dichotomous variables. Statistical heterogeneity in the results of the meta-analysis was assessed by graphical presentations of the confidence intervals (CI) on forest plots and by performing a χ2 test for heterogeneity, in which p = 0.1 was regarded as significant heterogeneity.

Data were analyzed using a random effect model and expressed in odds ratios and a Forest plot. Heterogeneity among the included studies was tested using the Cochrane Q test, with p values < 0.01 to ensure that odd ratios from separate studies were homogenously distributed. A funnel plot then was constructed to visually test for the presence of publication bias.

Sample Characteristics:

The total sample size included in the meta-analysis was 262.

Sample ranges across all studies in the meta-analysis was 10–139.

Sample characteristics of the studies in the meta-analysis were patients with vulval malignancies, inguinal lymphadenectomy, and saphenous vein preserved or sacrificed.

Results:

The search result defined few studies that reported results of saphenous vein sparing technique; some of those studies were found suitable for meta-analysis based on the Newcastle-Ottawa scale for nonrandomized studies. The meta-analysis showed significant reduction of lymphedema (odds ratio 0.24; 95% CI, 0.11–0.53) and other complications of inguinal node dissection. No randomized studies addressed this problem. Isolated studies reported on the benefits of other techniques, but none of them was suitable for meta-analysis.

Conclusions:

Meta-analysis of the reported studies on sparing the long saphenous vein in inguinal node dissection suggests a reduced rate of lymphedema and other postoperative complications.

Nursing Implications:

Other methods that may be beneficial are fascia preserving dissection, pedicledomental flap, and microsurgery. Sartorius transposition has not been shown to reduce the rate of complications. Randomized controlled trials are needed to prove the benefits of various technical modifications.

Studies were included in the review if they were related to lymphedema and involved eight or more patients.

Studies were excluded if they were not refereed articles.

Literature Evaluated:

The total number of references retrieved was not stated.

Studies were evaluated using an adapted checklist using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS) scale.

Sample Characteristics:

The final number of studies was 19.

Sample range across all studies was 9–1,800, with larger samples in retrospective descriptive studies

Key sample characteristics were not provided.

Results:

Findings were grouped according to the type of procedure: excisional (8 studies, 4 involving liposuction), lymphatic reconstruction (8 studies of lymphatic venous anastomosis [LVA]), and tissue transfer (4 studies involving lymph node transfer, stromal cell transplant, lymphatic tissue transplant, and lymph node transplant). Reduction in lymphedema volume was greatest after excisional procedures (91.1%). Lymphatic reconstruction was associated with 54.9% reduction, and tissue transfer with 47.6% reduction. Overall, surgical procedures did not appear to eliminate the need for compression therapy. Follow-up duration and methods of lymphedema measurement varied substantially across studies. Quality scores for studies ranged from 2–12 across all procedure types and tended to vary considerably within surgery type grouping as well. Studies were done in both upper and lower extremities, though most LVAs were done in lower extremities. The majority of studies did not comment on postoperative complications. Authors noted that a growing body of evidence supports the use of surgical procedures for prevention of lymphedema.

Conclusions:

Evidence related to the effectiveness of various surgical procedures for lymphedema is somewhat limited, and the ability to generalize findings also is limited given the wide variation in study quality, sample sizes, measurement methods, and lack of long-term follow up information. Surgical procedures have not been shown to eliminate the need for ongoing conventional therapies for lymphedema.

Limitations:

This review is limited by a lack of full information on search results, with consort type of flow charting, lack of information about disease types, and patient characteristics.

Nursing Implications:

Results of surgical procedures appear to show some promise for reducing lymphedema volumes. However, current evidence is too limited to generalize and more information is needed regarding postoperative complications or long-term results. Surgical intervention has not been shown to eliminate the need for ongoing conservative and conventional interventions as well.

Literature Evaluated:

The checklist from the American Society of Plastic Surgery for therapeutic studies was used for quality assessment.

Sample Characteristics:

The final number of studies included was 19 case reports involving a total of 191 patients.

The sample range across all studies was 6–127.

All patients had a breast cancer diagnosis.

Phase of Care and Clinical Applications:

Patients were undergoing the active antitumor treatment phase of care.

Results:

Four retrospective case series (n = 52) reported results of composite tissue transfer. Findings were rate of reduction in circumference, reduction in pain, reduced incidence of cellulitis, and improvement in quantitative lymph flow.

Two studies (n = 139) reported on lymph vessel transplantation. Outcomes included volume reduction and a case of donor site edema.

Four prospective case series evaluated microsurgery. Findings from these studies were mixed. Studies differed in terms of including patients with early nonfibrotic lymphedema or chronic lymphedema. A number of significant methodological limitations in the evidence were reviewed.

Derivative microsurgery was associated with relief of neuropathic pain in two studies for 50%–100% of patients.

Conclusions:

Very limited evidence exists regarding the efficacy of microsurgical techniques for the prevention and management of upper extremity lymphedema in patients with breast cancer who had axillary lymph node excision. The best findings were seen with inguinal lymph node transfer. Consistent positive findings and minimal reported adverse effects were reported. However, high quality-evidence is lacking.

Limitations:

Findings are limited because of the low number of studies, small samples, and lack of high-quality research. Additionally, follow-up duration varied, and most studies did not report rates related to the ability to discontinue conservative management for lymphedema.

Nursing Implications:

Microsurgical techniques for the prevention of lymphedema are promising; however, further high-quality research studies with long-term follow-up are needed.

Study Purpose:

To test the hypothesis that patients who receive a vapor-heated (VH) fibrin sealant in the inguinal wound following inguinal lymphadenectomy in conjunction with treatment of a vulvar neoplasm would experience a 25% reduction in the incidence of grade 2 and 3 lymphedema of the lower extremity compared to control patients

Intervention Characteristics/Basic Study Process:

Patients were randomized to the investigational or control arm of the study. In the investigational arm (FS), VH fibrin sealant was applied to the inguinal wound base. In the control arm (SC), the closure of the wound was performed without application of the fibrin sealant. Patients were assessed prior to treatment and postoperatively at the time of drain removal, at six weeks, and at three and six months.

Sample Characteristics:

The study sample (N = 137) was comprised of female patients with a vulvar malignancy.

Median age in the FS arm was 61 years, with a range of 30–90 years; median age in the SC arm was 57 years, with a range of 33–87 years.

All patients were undergoing a radical vulvectomy or hemivulvectomy with either an ipsilateral or bilateral inguinal lymphadenectomy.

Setting:

The study was conducted at multiple Gynecologic Oncology Group member institutions across the United States.

Study Design:

The study used a randomized phase III trial design.

Measurement Instruments/Methods:

Circumference was measured to determine leg lymphedema.

Surgical complications were measured, including vulvar wound separation, inguinal wound separation, grading of infection or cellulitis, and grading of seroma or lymphocyst.

Duration of drain and drain output in the 24 hours prior to drain discontinuation also were evaluated.

Results:

The incidence of grade 2 and 3 lymphedema was 67% in the SC arm and 60% in the FS arm (p = 0.4779). The incidence of lymphedema was strongly associated with inguinal infection (p = 0.0165). No statistically significant difference was found in duration of drains or drain output or incidence of inguinal infections, wound breakdowns, or seromas. The FS arm experienced an increased incidence of vulvar infections (p = 0.0098).

Conclusions:

VH fibrin sealant in inguinal lymphadenectomies does not reduce leg lymphedema and may increase the risk for complications in the vulvar wound.

Limitations:

The sample size in each group was small, with less than 100 participants.

Follow-up for circumferential measurement occurred only through six months.

The protocol prescribed 10–15 lb of pressure over the wound bed after the VH fibrin sealant had been applied, but the exact location and amount of pressure over the wound was not monitored.

Nursing Implications:

Future trials should be designed to evaluate surgical techniques and postoperative care that would decrease wound breakdowns and complications while monitoring for variables that may be related to increased incidence of swelling or lymphedema in patients with vulvar cancer.

Study Purpose:

To introduce key points relating to lower abdominal flap transplantation with vascularized lymph nodes, and to evaluate the effects of breast restoration or reconstruction and lymphatic transplantation to treat upper-arm lymphedema after breast cancer surgery

Intervention Characteristics/Basic Study Process:

Ten patients were recruited with postoperative, breast cancer-related lymphedema. Preoperatively, isotope radiography was used to determine lymphatic return obstruction. Patients were operated on in a standing position. A modified deep inferior epigastric perforator artery (DIEP) or microsurgical transverse abdominal myocutaneous island (TRAM) flap was accompanied by lymphatic tissue. The scar contracture of the axilla was relaxed and patients received abdominal transplantation of the lower abdominal flap with vascularized lymph node. Postoperatively, elastic bandages were applied for one year. Follow-up appointments occurred at one, three, six, and 12 months. The measurement indexes that were used included mid- and upper-arm circumference, clinical symptoms, and lymphoscintigraphy.

Sample Characteristics:

N = 10

AGE RANGE = 36–50 years

FEMALES: 100%

KEY DISEASE CHARACTERISTICS: Breast cancer-related lymphedema

OTHER KEY SAMPLE CHARACTERISTICS: All patients had lymphedema for three to five years.

Setting:

SETTING TYPE: Inpatient

LOCATION: Beijing, China

Study Design:

Controlled clinical trial

Measurement Instruments/Methods:

Isotope radiography

Multidetector-commuted tomography

Mid- and upper-arm circumference measurement

Clinical symptoms

Lymphoscintigraphy

Results:

All of the flaps worked. One patient experienced delayed wound healing. There was no obvious improvement in lymphedema in one patient. Seven patients saw improvements in lymphedema clinical symptoms and mean limb perimeter. One patient recovered. The mean reduction was 2.122 cm (SD = 2.331). Limb volume decrease was statistically significant between preoperative and postoperative measures (p < .05).

Conclusions:

Abdominal flap transplantation with vascularized lymph nodes and breast reconstruction, paired with treatment to upper-arm lymphedema and the use of elastic bandages as adjuvant treatment, is effective in restoring breast configuration and function.

Limitations:

Small sample (< 30)

Risk of bias (no control group)

Other limitations/explanation: Inconsistent study results, lack of standardized surgical technique, and short follow-up.

Nursing Implications:

This procedure may be effective for treating some women with breast cancer-related lymphedema, and it can guide future research on effective lymphedema therapy and postoperative monitoring.

OTHER KEY SAMPLE CHARACTERISTICS: All patients received three intradermal injections of Tc-labeled nanocolloid, and lymphoscintigraphy was performed one hour later. Operations were completed by the same surgeon, and SAD was completed up to Berg’s level III, with identification and preservation of the arm’s lymphatic hot spot when feasible.

Setting:

SITE: Single site

SETTING TYPE: Inpatient

LOCATION: Milan, Italy

Phase of Care and Clinical Applications:

PHASE OF CARE: Active antitumor treatment

Study Design:

The intervention group participated in the SAD intervention, and the control group usually had axillary lymph node dissection.

Measurement Instruments/Methods:

T test

Chi-square

Fisher’s exact test

Results:

SAD was successful in 45 of 60 patients. Four of 45 patients in the intervention group and five of 15 patients in the control group developed lymphedema (p = .072).

Conclusions:

BCRL with SAD technique after median follow-up of 16 months had 33% the rate of lymphedema occurence than conventional ALND. SAD technique requires a separate surgery from sentinel lymph node biopsy. Authors concede there may be a learning curve to this technique, and further research is needed to determine appropriate patient selection.

Limitations:

Small sample (< 100)

Risk of bias (no blinding)

Findings not generalizable

Other limitations/explanation: Relatively short follow-up to determine development of BCRL

Nursing Implications:

New surgical techniques may result in lowering patient morbidity but does not eliminate the possibility of patients developing BCRL. Education should continue to be provided to all patients regarding early identification of signs and symptoms of BCRL.

Study Purpose:

To review the effectiveness and safety outcomes of patients selected to receive surgical procedure for lymphedema (LE) after a program of complete decongestive therapy (CDT)

Intervention Characteristics/Basic Study Process:

LE therapy consisted of manual lymph drainage, compression bandaging and garments, and vascularized lymph node transfer (VLNT), which was used for upper extremity LE by removing lymph nodes from the groin and transferring them to the affected axilla or along with a deep inferior epigastric perforator (DIEP) flap. Lymphaticovenous anastomosis (LVA) was preferred for lower extremity LE, which was completed by connecting lymphatics to nearby microscopic veins. Both VLNT and LVA are for LE with primarily fluid component. Suction-assisted protein lipectomy (SAPL) is used to treat the solid type of LE and requires continued compression after procedure.

Measurement Instruments/Methods:

Change in compression garment use and lymphedema therapy necessary for VLNT and LVA

Change in the incidence of cellulitis in all cases

Results:

Good outcomes of volume reduction, decreased need for compression garments, and reduction of episodes of cellulitis were achieved for a small, selective group of patients who received one of three treatment procedures (VLNT, LVA, or SAPL coupled with CDT by a certified lymphedema therapist). The incidence of severe cellulitis decreased from 58% to 15% (p < 0.0001). Patients who underwent VLNT reported wearing their compression garments significantly less (p = 0.009) and needing less lymphedema therapy (p = 0.009). LVA was associated with a significant reduction in lymphedema therapy (p = 0.008) and trended toward significance in garment reduction (0.07). 88% of patients who underwent either VLNT or LVA showed a postoperative improvement in lymphedema symptoms. For patients who underwent SAPL, those who had arm lymphedema showed an average of a 111% reduction of excess fluid volume and those who had leg lymphedema showed an average reduction of 86% 12 months post operatively.

Nursing Implications:

CDT performed by a certified therapist is still needed for patients with lymphedema. This study identifies the surgical outcomes for selective patients, but it does not identify the specific inclusion or exclusion criteria for the surgical interventions. The average body-mass index for patients receiving one of the three interventions was 27.5. The relatively short interval of follow-up did not identify if the surgical interventions will continue to have the desired effects long-term. Financial reimbursement and payment issues were not addressed. The results may not be reproducible across all healthcare settings.

Study Purpose:

To evaluate the rate of lymphedema occurrence in patients who recieved a mastectomy and a sentinel lymph node biopsy (SLNB) with radiation therapy (RT) compared to an axillary lymph node dissection (ALND) with or without RT, with a secondary purpose to identify risk factors for development of lymphedema

Intervention Characteristics/Basic Study Process:

Mastectomies were categorized into four treatment groups: SLNB without RT, SLND with RT, ALND without RT, and ALND with RT. RT included the chest wall with or without supraclavicular or axillary radiation. Measurements were obtained pre- and postoperatively, during treatment for breast cancer, and at follow-up visits after the completion of breast cancer treatment.

Sample Characteristics:

N = 627

MEDIAN AGE = 50 years (range = 22–85 years)

FEMALES: 100%

KEY DISEASE CHARACTERISTICS: Individuals who underwent mastectomies after a diagnosis of primary breast cancer between September 2005 and February 2013.

Setting:

SITE: Single-site

SETTING TYPE: Not specified

LOCATION: Massachusetts General Hospital in Boston, United States

Phase of Care and Clinical Applications:

PHASE OF CARE: Multiple phases of care

Study Design:

Pre/post design with repeated measures

Measurement Instruments/Methods:

A perometer was used to measure arm volume.

Weight-adjusted arm volume change (WAC) was used to detect arm volume change in each arm individually.

Lymphedema was defined as a measurement of ≥ 10% WAC.

Results:

Of 664 mastectomies, 52% (343/664) were SLNB without RT, 5% (34/664) were SLNB with RT, 9% (58/664) were ALND without RT, and 34% (229/664) were ALND with RT. The two-year cumulative lymphedema incidence was 10% (95%, CI = 2.6%–34.4%) for SLNB with RT compared to 19.3% (95%, CI = 10.8%–33.1%) for ALND without RT and 30.1% (95%, CI = 23.7%–37.8%) for ALND with RT. The lowest cumulative incidence was 2.19% (95%, CI = .88%–5.40%) for SLNB without RT.

Conclusions:

Avoiding completion ALND and receiving SLNB with RT may decrease lymphedema risk in patients requiring a mastectomy. This study indicates that the application of the American College of Surgeons Oncology Group's Z0011 treatment protocol may reduce the risk of lymphedema for patients who receive a mastectomy.

Limitations:

Risk of bias (no random assignment)

Key sample group differences that could influence results

Other limitations/explanation: The group that received SLNB without RT was small (n = 34). Less than half (44%) of patients who received SLNB without RT had a positive SLNB. This was a single-site study.

Nursing Implications:

The study provides nurses with information about SLNB with RT and how its use may decrease the risk of developing lymphedema compared to patients who recieve ALND. However, the nonrandomized, controlled trial design and the different sample sizes of each study group limit the ability to generalize this study's findings. Future randomized, controlled studies are warranted.

Study Purpose:

Intervention Characteristics/Basic Study Process:

The intervention group underwent the LVA procedure. Before incision of the skin in the inguinal region, blue dye was injected in the thigh muscles to identify the lymphatic vessels draining the leg. Lymphatic venous anastomosis was performed by inserting the blue lymphatics coming from the lower limb into one of the collateral branches of the femoral vein (telescopic end-to-end anastomosis). For the intervention group, circumferential measurements were assessed at preoperation, at drain removal, at eight weeks and four months postsurgery, and during routinely follow-up examinations. A lymphoscintigraphy was performed one month postsurgery. For the control group, circumferential measurements were taken at routine cancer surveillance examinations. Lymphoscintigraphies were performed at variable intervals of time from the surgery.

Sample Characteristics:

N = 15

AGE RANGE = 54–87 years

MALES: 0%, FEMALES: 100%

KEY DISEASE CHARACTERISTICS: Patients with histologically confirmed invasive carcinoma of the vulva, requiring either unilateral or bilateral ILND, entered the study from November 2009 to June 2011.

OTHER KEY SAMPLE CHARACTERISTICS: 1 mm or greater stromal invasion, stage IB–III (according to International Federation of Gynecology and Obstetrics classification), and performance status of less than 2 according to the World Health Organization.

Setting:

SITE: Single site

SETTING TYPE: Not specified

LOCATION: University of Genoa, Italy

Phase of Care and Clinical Applications:

PHASE OF CARE: Mutliple phases of care

Study Design:

Quasi-experimental design

Measurement Instruments/Methods:

Circumferential measurement of the ankle, midcalf, and midthigh

Lymphoscintigraphy: Transport index

Results:

In the study group, four patients underwent bilateral ILND, and four patients underwent unilateral ILND. Blue-dyed lymphatics and nodes were identified in all patients. It was possible to perform LVA in all the patients. The mean time required to perform a monolateral LVA was 23.1 minutes (SD = 3.6; range, 17–32 minutes). The mean follow-up was 16.7 months (SD = 6.2); there was only one case of grade 1 lymphedema of the right leg. Lymphoscintigraphic results showed total mean transport index were 9.08 and 14.54 in the study and the control groups, respectively (p = 0.092).

Conclusions:

This study shows, for the first time, the feasibility of LVA in patients with vulvar cancer undergoing ILND. Although no significant difference noticed in lymphoscintigraphy at one month postsurgery, a trend toward a smaller mean of transport index was noted in the study group. Future studies with larger samples sizes are needed.

Limitations:

Small sample (< 30)

Baseline sample/group differences of import

Risk of bias (no blinding)

Risk of bias (no random assignment)

Other limitations/explanation: Different follow-up schedule between the two study groups; short follow-up; single-site study

Nursing Implications:

The study provides nurses with updated information about potential feasibility and early clinical outcome of LVA in patients with vulvar cancer undergoing ILND. However, the small sample size, non-randomized, controlled trial design, as well as short follow-up do not allow the researchers to draw definitive conclusions on the effectiveness of LVA technique in this population. Future large, long-term follow-up randomized, controlled trials are warranted.

Study Purpose:

To report the experience with a new technique, axillary reverse mapping (ARM), in patients scheduled for axillary lymph node dissection (ALND) and to evaluate its usefulness for reducing the incidence of lymphedema

Intervention Characteristics/Basic Study Process:

For the intervention group, blue dye was injected subcutaneously along the intermuscular groove of the upper inner arm; radioisotope was injected subcutaneously in the interdigital webspace of the hand. All blue and radioactive lymph vessels and lymph nodes were recorded. Only unsuspicious ARM lymph nodes located in the lateral part of the axillary basin were preserved. All other level I and II axillary lymph nodes were removed. One follow-up was conducted at a median of 19 months.

Phase of Care and Clinical Applications:

Study Design:

Measurement Instruments/Methods:

Results:

ARM was performed in 143 patients subsequently undergoing ALND. ARM lymph nodes were successfully identified in 112 patients (78%). In 55 patients, at least one ARM lymph node had to be removed. In 14 of these, tumor involvement was confirmed. In 71 patients, one or more ARM nodes were preserved. During a median follow-up time of 19 months, no axillary recurrence was noted. Thirty-five of 114 evaluated patients developed lymphedema. Preservation of ARM lymph nodes did not significantly decrease the incidence of lymphedema

Conclusions:

ARM is feasible for patients with node-positive breast cancer. However, the study found no evidence that it reduces the incidence of lymphedema.

Limitations:

Risk of bias (no control group)

Risk of bias (no random assignment)

Other limitations/explanation: Single0site study, non-RCT design, no baseline arm volume measure, and borderline power of the sample size

Nursing Implications:

Larger studies with rigorous design are needed to evaluate whether preservation of clinically unsuspicious ARM nodes is oncologically safe and effective in preventing secondary lymphedema in patients with breast cancer.